Updated: Today
Location: Adelaide, SA, Australia
Job ID: 25109253
Syneos Health is a leading fully‐integrated life sciences services organization that accelerates customer success across the drug development continuum.
Why Syneos Health
* We are passionate about developing our people through career development, supportive line management, technical and therapeutic area training, peer recognition, and a total rewards program.
* We are committed to building an inclusive culture where you can authentically be yourself.
* We continuously build a company we all want to work for and our customers want to work with.
Job Responsibilities
* Perform site qualification, initiation, interim monitoring, site management and close‐out visits (on‐site or remotely) ensuring regulatory, ICH‐GCP and GPP compliance.
* Verify informed consent process and maintain confidentiality of subjects and patients.
* Assess site processes and conduct source document review, ensuring data accuracy and completeness.
* Apply query resolution techniques and support the effective conduct of clinical study data review.
* Manage investigational product inventory, reconciliation, and storage/security.
* Review Investigator Site File, reconcile with Trial Master File, and ensure compliance with archiving regulations.
* Document activities and support recruitment, retention, and awareness strategies.
* Manage project scope, budgets, and timelines for the clinical team.
* Act as primary liaison with site personnel and collaborate with Central Monitoring Associate.
* Prepare for and attend investigator and sponsor meetings; lead project staff meetings when needed.
* Provide guidance toward audit readiness and support audit preparation.
* Train and mentor junior CRAs, including sign‐off visits.
* Additional responsibilities for Real World Late Phase (RWLP) candidates:
o Site support through the study lifecycle.
o Understand local requirements for RWLP designs.
o Chart abstraction and data collection.
o Build relationships with sponsor, affiliates, medical science liaisons, and local staff.
o Communicate out‐of‐scope activities to Lead CRA/Project Manager.
o Suggest potential sites based on local treatment patterns, advocacy, and HCP associations.
o Identify operational efficiencies and process improvements.
o Develop country‐level informed consent forms.
o Collaborate with RWLP Regulatory team for regulatory updates.
o Participate in bid‐defense meetings.
Qualifications
* Bachelor's degree or RN in a related field, or equivalent combination of education, training, and experience.
* Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
* Strong computer skills and willingness to embrace new technologies.
* Excellent communication, presentation, and interpersonal skills.
* Basic critical thinking skills.
* Ability to travel up to 75% of the time.
Equal Employment Opportunity
We are an Equal Opportunity Employer. Our policies comply with the EU Equality Directive and the Americans with Disabilities Act. We are committed to providing reasonable accommodations to assist employees and applicants to perform the essential functions of the job.
#J-18808-Ljbffr